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IJBCP International Journal of Basic & Clinical Pharmacology Assessment Print ISSN: 2319-2003 | Online ISSN: 2279-0780 IJBCP International Journal of Basic & Clinical Pharmacology DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20194789 Original Research Article Assessment of knowledge, attitudes and practice among interns about over the counter drugs in a tertiary care hospital in India Sudipto Chatterjee, R. Vijendra*, K. Girish, Mahesh Kumar Manjeri Koroth Department of Pharmacology, Kempegowda Institute of ABSTRACT Medical Science, Bangalore, India Background: Drugs that are dispensed against a valid prescription issued to a patient by a registered medical practitioner are known as “prescription-only Received: 18 September 2019 drugs”. In India, they have been regulated under schedule H, H1, G, and X of Revised: 11 October 2019 the Drugs and Rules (1945). The drugs which are not included in the list of Accepted: 14 October 2019 “prescription-only drugs” are considered to be over-the-counter drugs (OTC). There is no provision for an OTC drug schedule in the Drugs and Cosmetics *Correspondence to: Rules 1945, and these drugs have higher chances of misuse or abuse. This study Dr. R. Vijendra, was undertaken to assess the knowledge, attitudes and practice among medical Email: vijendra_ramaiah@ interns about OTC drugs in a tertiary care hospital in India. yahoo.co.in Methods: This was a cross-sectional study, which was conducted at Kempegowda Institute of Medical Sciences and Research Center, Bangalore, Copyright: © the author(s), Karnataka, India, from March 2018 to September 2018. A pre-validated publisher and licensee Medip questionnaire consisting of 24 questions to assess the knowledge, attitude, and Academy. This is an open- practice was administered to 80 medical interns chosen by simple access article distributed under randomization, out of which 14 questions were related to knowledge, 6 related the terms of the Creative to attitude and 4 related to the practice. The participants were provided 30 Commons Attribution Non- minutes to complete the questionnaire. The data recorded were analyzed using Commercial License, which Microsoft Excel. permits unrestricted non- Results: There were some gaps in the knowledge, attitude and practice among commercial use, distribution, the medical interns about OTC medications. and reproduction in any Conclusions: There is a need for special emphasis on the MBBS curriculum medium, provided the original about the use of OTC drugs. work is properly cited. Keywords: Attitude, Knowledge, Practice, OTC drugs, Interns INTRODUCTION and in the case of substances specified in Schedule X, the prescriptions shall be in duplicate, one copy of which Over-the-counter (OTC) medications are non-prescription shall be retained by the licensee for a period of two medications, i.e., these medications can be sold directly years”. to a consumer without a prescription from a qualified and registered healthcare professional.1 Most of the drugs are The Drugs and Cosmetics Rules (1945) classify drugs sold by a retail pharmacist only against a prescription of a into different schedules providing guidelines for storage, registered medical practitioner. These are “prescription- sale, display and prescription of drugs under each only drugs”, and in India, they have been placed in schedule. The major schedules include: Schedule H, H1, G, and X of the Drugs and Cosmetic Act (1940). Schedule G Drugs and Cosmetics Act (1940) states “substances Includes hormonal and anti-hormonal, anti-diabetic, anti- specified in Schedule H and Schedule H1 or Schedule X neoplastic agents, etc., e.g., metformin, aminopterin, l- shall not be sold by retail except on and in accordance asparaginase, bleomycin, busulphan. with the prescription of a registered medical practitioner www.ijbcp.com International Journal of Basic & Clinical Pharmacology | November 2019 | Vol 8 | Issue 11 Page 2485 Chatterjee S et al. Int J Basic Clin Pharmacol. 2019 Nov;8(11):2485-2489 Schedule H METHODS Drugs are to be sold by retail on the prescription of a This was a cross-sectional study, which was conducted at registered medical practitioner only. Majority of the Kempegowda Institute of Medical Sciences and Research prescription drugs are included in this schedule. Center (KIMS and RC), Bangalore, Karnataka, India, Presently, there are 536 drugs included in this schedule. from March 2018 to September 2018. A questionnaire E.g., allopurinol, colchicine. was prepared which consisted of 24 questions. Among them, 14 were related to the knowledge, 6 were related to Schedule H1 attitude and the remaining 4 questions were related to the practice aspects.4 This was validated by logical Include drugs which need to be very judiciously in order validation. The study was commenced after obtaining to prevent misuse and/or prevent development of drug approval from the KIMS institutional ethics committee. resistance. The Government of India on August 30, 2013, The questionnaires were administered to the consenting had made an amendment to the Drugs and Cosmetics Act participants- 80 medical interns of KIMS and RC, of 1940 and introduced the Schedule H1. Drugs included Bangalore. Approximately, 30 minutes were provided to under this schedule are antimicrobial agents including the participants for filling up the questionnaires. The data antitubercular drugs and such other drugs which should were analyzed using Microsoft Excel. be used sparingly in the general population. The details of the drugs should be recorded in a separate register at the time of the supply by the pharmacist mentioning the Questionnaire based cross-sectional study name and address of the prescriber, along with the name of the patient and the name of the drug with the quantity supplied. E.g., alprazolam, doripenam, balofloxacin, IEC clearance ertapenem, buprenorphine, capreomycin, ethionamide, cefdinir, feropenam, cefditoren. Schedule X Conducted at KIMS and RC, Bangalore Include those drugs where the retailer should preserve the prescription for a period of two years. It includes Sample size: 80 controlled drugs and drugs which have high likelihood of abuse and misuse. E.g., amobarbital, glutethimide pentobarbital, ketamine hydrochloride, amphetamine, meprobamate, phencyclidine, barbital, 24 questions: methamphetamine. Knowledge-based (14) Attitude-based (6) The Drugs and Cosmetics Rules (1945) also mandates Practice-based (4) that the drug label should contain the texts “Rx” in case of a Schedule H drug; “NRx” in case where the drug falls under the Narcotic Drugs and Psychotropic Substances Act, 1985; and “XRx” in case of a Schedule H drug. Time provided to participants (30 minutes) These labels shall be in red conspicuously displayed on the left top corner of the label.2 Currently, there is no OTC drug schedule in the Drugs Data captured in MS Excel and Cosmetics Act. As of now, drugs which are outside schedule H, H1, G, and X are considered to be an OTC 3 drug. The likelihood of misuse of drugs is, therefore, Analysis of the data 4 more with the OTC drugs. Some essential characteristics of OTC drugs includes Figure 1: Methodology. high margin of safety and effectiveness, low potential for misuse and abuse, useful for self-diagnosable, conditions The questionnaire was framed to elicit the knowledge of and have adequate labeling for consumers.5 the participants (14 questions) including knowledge about the drug schedules, commonly used drugs such as Objectives analgesics, antimicrobials and sedatives, their appropriateness of usage, knowledge about drug The study was undertaken to assess the knowledge, interactions and adverse reactions and use of herbal drugs attitudes and practice among medical interns about OTC (Questions 1 to 14). It also included questions to elicit drugs in a tertiary care hospital in India. their attitude including concern of misuse of International Journal of Basic & Clinical Pharmacology | November 2019 | Vol 8 | Issue 11 Page 2486 Chatterjee S et al. Int J Basic Clin Pharmacol. 2019 Nov;8(11):2485-2489 antimicrobial drugs, self-medication, and updating their schedule under the Drugs and Cosmetics Act. Knowledge knowledge of OTC medications (Questions 15 to 20). about some common drugs (alprazolam and levofloxacin) The practice-based questions elicited information included under Schedule H1 was inadequate. Knowledge regarding how they updated their information regarding about the dangers (GI perforation) of commonly used OTC drugs, how they dealt with misuse and abuse of the sodium bicarbonate containing antacids was lacking in OTC drugs and the sources for obtaining information many respondents (n=45; 55.13%). A must known fact about OTC drugs (Question 21 to 24). about dangers of aspirin use in children (Reye’s syndrome) was also lacking in many respondents (n=31; RESULTS 37.97%). Only 68.75% of respondents (n=55) believed that OTC drugs can cause severe adverse effects. The results of the study captured as responses to the questionnaire are depicted in the form of tables and Most of the respondents showed appropriate responses to graphs. questions regarding their attitude with regards to the OTC drugs (Table 2). Significant gaps also were present in the Table 1 indicates the correct responses to the questions attitude of the respondents regarding the appropriateness which elicited the understanding and knowledge of the of antimicrobials to be used as OTC agents (n=11; respondents about OTC drugs. Significant gaps were 13.75%), increased risk of self-medication with OTC noticed in the responses from the respondents with drugs (n=5; 6.25%). Attitude regarding putting an age bar regards to the knowledge about OTC drugs in India. Most for obtaining OTC drugs (n=5; 6.25%), potential for respondents (n=47; 58.75%) believed that “OTC drugs” misuse of OTC drugs (n=2; 2.50%) and restriction of had a legal backing in India, which is not true. “OTC OTC drugs (n=12; 15%) can be considered to be drugs” have not been defined or included in a separate inappropriate. Table 1: Knowledge-based questions. Participants providing Sl. Correct Questions correct response No. response N (%) Schedule H, H1, G, X drugs can be given only with a 1 Yes 75 (93.75) prescription of a registered medical practitioner.
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